MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEM; MAXILLA CUTTING GUIDE

Catalog Number	VSPO-550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a maxillofacial surgery involving vsp system devices, the surgeon reported that the left maxilla guide was not seating properly on the patient's bony anatomy and the surgeon decided not to proceed with the operation.

• Brand Name: VSP SYSTEM
• Common Device Name: MAXILLA CUTTING GUIDE
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 s alkire st; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 s alkire st; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5281 s alkire st; littleton, CO 80127
• MDR Report Key: 22851702
• Report Number: 1724955-2025-00008
• Device Sequence Number: 8403457
• Product Code: DZJ
• UDI-Device Identifier: 00816847020831
• UDI-Public: (01)00816847020831(10)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VSPO-550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Unknown